法规知识库 · EMA 集中审评
Cubicin
daptomycin · EMEA/H/C/000637 · 已授权
获批上市许可
2006-01-19
欧委会决定日
2025-11-07
持有人 / 申请人
未知
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
17
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J01XX09
治疗领域：Gram-Positive Bacterial Infections;Bacteremia;Soft Tissue Infections;Endocarditis, Bacterial
药理分类：Antibacterials for systemic use
修订号：41 · 最新影响 PI 的程序：N/0000310384
适应症（原文）：Cubicin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2025-11-07 · 欧委会决定
2006-01-19 · 获批上市许可
2005-11-17 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Cubicin : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-07
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Cubicin : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-28
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Cubicin : EPAR - Risk management plan
rmp · 2025-01-16
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Cubicin : EPAR - Summary for the public
overview · 2022-12-14 · EMEA/H/C/000637
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Cubicin-H-C-637-P46-035 : EPAR - Assessment report
variation-report · 2021-04-08 · EMA/158534/2021
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Cubicin-H-C-PSUSA-00000931-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-07-04 · EMA/446384/2018
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Cubicin-H-C-637-P46-034.1 : EPAR - Assessment Report
variation-report · 2018-04-18 · EMA/CHMP/238693/2018
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Cubicin-H-C-637-II-0061 : EPAR - Assessment Report - Variation
variation-report · 2018-01-04 · EMA/683418/2017
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Cubicin-H-C-PSUSA-00000931-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-07-28 · EMA/321854/2017
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Cubicin-H-C-637-P46-0033 : EPAR - Assessment Report
variation-report · 2017-01-05 · EMA/2925/2017
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Cubicin-H-C-637-P46-0032 : EPAR - Assessment Report
variation-report · 2016-07-05 · EMA/CHMP/2543/2016
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Cubicin-H-C-637-II-0053/G : EPAR - Assessment Report - Variation
variation-report · 2016-01-28 · EMA/CHMP/654096/2015
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Cubicin-H-C-637-P46-007.5 : EPAR - Assessment Report
variation-report · 2015-07-09 · EMA/460377/2015
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Cubicin-H-C-637-P46-030.1 : EPAR - Assessment Report
variation-report · 2015-05-18 · EMA/CHMP/322551/2015
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Cubicin-H-C-637-II-0005 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-10-11
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Cubicin : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-08-11
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Cubicin : EPAR - Scientific Discussion
scientific-discussion · 2006-08-11
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。